Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1391-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential for physical defect (tearing) and substance transfer without reported injuries or hospitalizations, fitting the Moderate severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000 Camera Arm Drape, 20 Pack (Product number 420279-03). These drapes are used to cover surgical and non-surgical equipment in clinical settings. The recall involves 442,475 units distributed worldwide to numerous countries, including the United States.

The recall was initiated because the drapes may exhibit a cloudy or waxy appearance. This defect creates a potential for the drape to tear and for a waxy substance to transfer to the patient during use.

Healthcare facilities should stop using the affected drapes and contact Intuitive Surgical for instructions on how to return or dispose of the product. The specific lot numbers affected are listed in the official FDA recall record Z-1391-2015.

The recalled product

Product: da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Drapes
Hazard: material-defect
contamination
Affected units: 442,475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product number 420279-03
da Vinci Si Camera Arm Drape
20 Pack. Lot Numbers: D142175
D142175A
D142185
D142185A
D142195
D142195A
D142205
D142205A
D142215
D142215A
D142235
D142235A
D142245
D142245A
D142255
D142255A
D142265
D142265A

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same manufacturer · Intuitive Surgical, Inc.

See all →

Moderate
da Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
Severe
Da Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
High
Da Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
High
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
Severe
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13

Same hazard · material defect